Identity
- Trade Name
- 22 Gauge Black Tips FDA UDI
- Generic Name
- Dental material injection cannula, reusable FDA UDI
- Device Name
- Luer Lock Tip EUDAMED
- Model / Reference
- 203104 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- D7792031040 EUDAMEDD77920310412 FDA UDI
- Basic UDI-DI
- ++D779LUERLOCKTIPS7B EUDAMED
- FDA Product Code
- EID FDA UDI
- EMDN Code
- Q019006 DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE EUDAMED
- GMDN Term
- Dental material injection cannula, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material injection cannula, single-use
Luer Lock Tip by Cosmedent, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D779LUERLOCKTIPS7B | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cosmedent, Inc.
- EUDAMED SRN
- US-MF-000045496
- Authorised Representative
- SAS Exclusivas Dentales S.L. ES-AR-000045423
Sources (2)
- EUDAMED bf030b88-7608-4ce0-afd8-f0538e253fa9 61 fields · synced Jul 30, 2026
- FDA UDI 2c5dd0b8-e925-49d4-8e75-458d120b493c 32 fields · synced May 29, 2026